EP3742176A1 - Telescoping closed-tube sampling assembly - Google Patents
Telescoping closed-tube sampling assembly Download PDFInfo
- Publication number
- EP3742176A1 EP3742176A1 EP20185035.1A EP20185035A EP3742176A1 EP 3742176 A1 EP3742176 A1 EP 3742176A1 EP 20185035 A EP20185035 A EP 20185035A EP 3742176 A1 EP3742176 A1 EP 3742176A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- tube
- sample
- probe
- piercing
- lumen
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
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Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
- G01N35/026—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations having blocks or racks of reaction cells or cuvettes
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/02—Burettes; Pipettes
- B01L3/021—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L13/00—Cleaning or rinsing apparatus
- B01L13/02—Cleaning or rinsing apparatus for receptacle or instruments
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
- G01N35/1004—Cleaning sample transfer devices
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
- G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
- G01N35/1011—Control of the position or alignment of the transfer device
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
- G01N35/1079—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices with means for piercing stoppers or septums
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/0672—Integrated piercing tool
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/04—Moving fluids with specific forces or mechanical means
- B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
- B01L2400/0487—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure fluid pressure, pneumatics
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
- G01N35/1004—Cleaning sample transfer devices
- G01N2035/1006—Rinsing only the inside of the tip
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/11—Automated chemical analysis
- Y10T436/113332—Automated chemical analysis with conveyance of sample along a test line in a container or rack
- Y10T436/114998—Automated chemical analysis with conveyance of sample along a test line in a container or rack with treatment or replacement of aspirator element [e.g., cleaning, etc.]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
- Y10T436/2575—Volumetric liquid transfer
Definitions
- the invention relates to a clinical diagnostic analyzer for analyzing fluid samples such as patient blood samples. More particularly, the invention relates to a closed tube sample collecting device including a piercing probe and sample probe assembly mounted on a clinical diagnostic analyzer for accessing a fluid in vial, venting mechanisms associated with the closed tube sample collecting device, and methods for sampling and clearing a closed tube sample collecting device between patient samples to prevent cross contamination of the blood samples.
- a sample In order to analyze samples of patient fluids, including human blood, a sample must first be taken from the patient. Usually the sample is housed within a container to be aspirated from during analyzer operation. These sample containers are then loaded into an automatic sample analyzer. If the sample container is capped, the cap must first be removed before a sample can be aspirated for analysis. This can be done manually by the operator, or, if the sample container has a frangible seal, the analyzer may contain a piercing apparatus to break the seal on the container to allow aspiration of a fluid sample.
- sample aspirator in a dual mode to break the frangible seal, as well as to aspirate sample.
- the use of the sample aspirator in the dual mode may cause blockage of the sample aspirator if fragments of the seal enter the tip of the aspirator or the venting apertures disposed on the sample aspirator.
- some analyzers use a piercing device that is separated from the sampling device.
- the piercing device is located in close proximity to the sampling device; however, in some devices the piercing device and sampling device may be located in different areas of the analyzer. Consequently, additional time is required to first position the sample tube for piercing and to then either reposition the sample in relation to the sample aspirator, or to move the sample aspirator to the location of the sample vial. These movements increase the throughput time of the sample analyzer, thus decreasing its efficiency.
- sample analyzers may only be able to aspirate sample from one type of vial or sample container at a time. Consequently, if an operator had multiple samples in different sized vials, only similar containers could be processed in the same batch. A new cycle or additional analyzer calibration would be required for each style of vial present. The inability of a sample analyzer to process different sized vials in the same batch negatively affects the throughput time of the analyzer, decreasing its efficiency.
- the improved sample analyzer reduces or eliminates the problems associated with current devices used to pierce sample vial caps, reduces clogging of both the piercing and sampling mechanisms thereby reducing cross-contamination, improving the accuracy of aspirating sample volumes, and improves access to samples in a variety of differently sized sample tubes.
- the present invention provides a clinical diagnostic analyzer comprising an assembly for obtaining a sample of fluid from a fluid sample tube or vial.
- the invention also provides a method for sampling fluid from a fluid sample tube or vial.
- the invention provides a clinical diagnostic analyzer comprising a sample collecting device for sampling fluid in a container.
- the device includes a first tube comprising a lumen and a piercing end, a second tube comprising a lumen and a free end, and a valve operatively joined to the piercing tube, the valve comprising an open position and a closed position, and a positive pressure gas source for generating positive gas pressure operatively joined to the valve.
- the positive gas pressure generated by the positive pressure gas source purges the piercing tube lumen when the valve is in the open position.
- the second tube is at least partially housed within the lumen of the first tube and the free end of the second tube transitions from an enclosed position within the lumen of the first tube to a deployed position beyond the piercing end of the first tube. At least one of the first or the second tube axially moves relative to the other. The second tube samples fluid in the container when the free end of the second tube is deployed relative to the piercing end of the first tube.
- first tube and the second tube move simultaneously with one another, while in another embodiment, the second tube is stationary and the first tube moves relative to the second tube. In yet another embodiment, the first tube is stationary while the second tube moves relative to the first tube.
- the second tube is coupled to an assembly for passing a gas, e.g., air through the lumen of the second tube, while in yet another embodiment, the first tube is coupled to an assembly for passing a cleaning solution through the lumen of the first tube.
- a gas e.g., air
- the apparatus includes a mechanism for triggering the apparatus to pierce the cap of and sample from a sample tube.
- the mechanism includes a sensor system and an activating member that triggers the apparatus when the member contacts the sample tube.
- the member may be a foot assembly.
- the piercing end of the first tube is cut on an angle to reveal an elliptical cross section.
- the end is beveled.
- the apparatus is coupled to a first carriage assembly to permit movement of the apparatus in a first axis of the analyzer, while in a further embodiment, the first carriage assembly is coupled to a second carriage assembly to permit movement of the apparatus in a second axis of the analyzer.
- the analyzer may also comprise at least one motor and a computer.
- the apparatus further comprises an information processing unit for receiving and sending information to a computer.
- the first tube may be coupled to a spring-loaded assembly.
- the valve of the device is a two-way valve.
- the device may include one, two, or more two-way valves arranged in series or in parallel.
- the first valve is operatively joined to the positive pressure gas source and the second valve is operatively joined to room air at atmospheric pressure.
- the valve is a three-way valve and the three way valve is operatively joined to the piercing tube, to the positive pressure gas source, and to room air at atmospheric pressure.
- the sample collecting device further includes an accumulator.
- the accumulator is operatively joined to the valve and to the positive pressure gas source.
- the accumulator is pressurized from about 25 PSIA to 30 PSIA; preferably 27 PSIA.
- the device further includes a gas pressure sensor. The gas pressure sensor is operatively joined to the positive pressure gas source.
- the present invention provides a clinical diagnostic analyzer including an apparatus for sampling fluid in a container.
- the apparatus includes a first non-perforated tube reciprocally movable in a vertical axis comprising a lumen, a piercing end and another end in communication with a conduit, and a second non-perforated tube comprising a lumen and a free end.
- the second tube is inseparable during sampling from, and is at least partially housed within the lumen of the first tube.
- the free end of the second tube transitions from an enclosed position within the lumen of the first tube to a deployed position beyond the piercing end of the first tube.
- the first tube moves axially relative to the second tube.
- the second tube moves axially relative to the first tube or alternatively, both tubes move axially relative to each other.
- the second tube samples fluid in the container when the free end of the second tube is deployed relative to the piercing end of the first tube.
- the piercing end of the first tube may be for example, beveled, cut at an angle to reveal an elliptical cross section, chamfered, or the inner edges of the free end may be rounded.
- the clinical diagnostic analyzer includes a spring operatively joined to the first tube to effect movement of the first tube.
- the first tube may further feature one or more detents for positioning the first tube in its vertical axis.
- the analyzer includes a ' sensor system that engages a member contacting the sample tube to determine when a sample tube is in position for piercing and sampling.
- the member may be, for example, a foot assembly comprising a through hole.
- the apparatus of the clinical diagnostic analyzer is coupled to a first carriage assembly to permit movement of the apparatus in a first axis of the analyzer.
- the first carriage assembly is coupled to a second carriage assembly to permit movement of said apparatus in a second axis of said analyzer.
- the clinical diagnostic analyzer includes a washing station.
- the washing station may include a washing container, a radial rinser, a filter, and/or a gas jet, or any combination of the above.
- the filter is disposed in the lumen of the washing container.
- the radial rinser features a plurality of radially arranged rinser ports.
- the apparatus according to the invention may further include an air purge system comprising a tube with an orifice positioned adjacent the tip of the first tube, the air purge system operatively joined to a gas source
- the clinical diagnostic analyzer includes a pressurized gas source in communication with the lumen of the first tube for purging residual fluid in the lumen.
- the clinical diagnostic analyzer features a second tube coupled to an assembly for passing fluid through the lumen of the second tube.
- the first tube is operatively joined to a sensor to detect contact of the first tube with a fluid or a solid.
- the second tube is operatively joined to a sensor to detect contact of the second tube with a fluid or a solid.
- the first tube and the second tube are joined by a circuit to prevent signal of false detection of the other tube.
- the present invention is related to a telescoping piercing probe and sample probe assembly and a venting mechanism mounted on a clinical diagnostic analyzer for automated piercing and sampling of fluid in a vial.
- the assembly includes a sample probe housed within a piercing probe. All of the following embodiments of the invention include features that improve the efficiency and effectiveness of an automated diagnostic sample analyzer including the piercing probe and sample probe assembly, and the venting mechanism of the invention.
- a sample collecting device 18 for example, a closed tube sample collecting device, is a component of an automated clinical diagnostic analyzer 10 that analyzes patient blood samples.
- the clinical diagnostic analyzer 10 may further include an analysis station 4, a wash station 9, a processor 8, a drive motor 90 and a sample tube rack 96.
- the sample tube rack 96 includes a plurality of sample tube wells 98.
- a patient blood sample, contained within a sample tube 7, rests within a sample tube well 98.
- the sample collecting device 18 may collect samples from a variety of sized and shaped sample tubes 7, including both closed sample tubes 7, cups (not shown), vials (not shown), and open sample tubes.
- the closed sample tubes 7 include a sample tube cap or seal 37 to seal the sample from the atmosphere and particulate debris.
- the sample collecting device 18 includes a sampling assembly 3 comprising a piercing tube 36 comprising an axially-disposed lumen 35, and a sample aspirating probe 30 including an axially disposed lumen 33.
- the sample collecting device 18 may also include one or more valves 40, an accumulator 62, and a positive pressure gas source 70.
- the sampling assembly 3 is mounted to a carriage assembly which travels via a bearing rail 5 of an arm 1.
- the arm 1 is also attached to a second carriage assembly which travels on a second bearing rail (not shown).
- a cuvette dispenser (not shown) is positioned at the rear of the analyzer 10 to dispense cuvettes (not shown) that receive the sample obtained by the sampling assembly 3.
- the cuvettes are transported by a tube transport mechanism (not shown) to the analysis station 4 such as, for example, a luminometer.
- a further embodiment of the analyzer 10 includes a washing station 9.
- the washing station 9 cleans the piercing probe 36 and sample probe 30 of the sampling assembly 3 after the sample removed from the sample tube 7 is dispensed into a cuvette (not shown).
- the washing station 9 includes a container 200 of washing fluid and a spray device, e.g., a shower 180 that sprays a washing fluid directed to the contaminated piercing probe 36 and/or sample probe 30.
- the washing station 9 further includes a filter 184 for removing debris.
- the filter 184 may be substantially cylindrical, disc-shaped or conical. In a particular embodiment the filter is cylindrical and disposed in the lumen of the washing container.
- the washing station 9 includes a jet 160 connected to a gas source (not shown) for directing a blast of drying gas to the distal end of the piercing probe to dry the probe.
- a computer controls the overall activity of the analyzer 10 by receiving input from the various sensors and information processing units of the analyzer 10 and directing the movement of the various parts of the analyzer 10, such as the movement of the positioning arm 1 along the rail 5, according to one embodiment of the invention.
- the movement of the positioning arm 1 is driven by a motor 90.
- the clinical diagnostic sample analyzer 10 shown here is only one example of an analyzer utilizing the sampling assembly 3 of the invention.
- the sampling assembly 3 may be used according to the invention with any appropriately configured clinical diagnostic sample analyzer.
- FIG. 3 depicts an exemplary piercing probe 36 of the invention.
- the piercing probe 36 is a tubular structure including a distal end, a proximal end, and an axially disposed lumen 35 that opens on the distal and proximal end of the tubular structure.
- the walls of the tubular structure are non-perforated; i.e., without holes, ports or vents.
- the piercing probe 36 is reciprocally movable in a vertical axis.
- a tip 32 for piercing a sample tube 7 is disposed at the distal end of the piercing probe 36, while the piercing probe 36 proximal to the tip 32 has at least a first detent 42 and a second detent 44 proximal to the first detent 42. Additional detents may also be included in the probe 36 according to alternative embodiments of the invention. According to a particular embodiment, the piercing probe 36 includes only one detent (not shown). The first and second detents assist in positioning the piercing probe 36 relative to the sampling probe 30 and will be discussed further below. The proximal end of the piercing probe 36 also may be in communication with a conduit.
- the tip 32 of the piercing probe 36 shown in FIG. 3 is beveled and reveals an elliptical cross-section, the tip 32 may be cut at any angle. As shown in FIGS. 4A-C , the tip may also be one of a variety of different shapes, e.g., diamond, circular, oval, rectangular, toothed and scalloped, for example.
- FIG. 4A shows a cutaway view of the distal portion of an exemplary piercing probe 36 including a blunt tip 32 that includes a chamfered edge according to one embodiment of the invention.
- FIG. 4B shows a side view of the portion of the exemplary piercing probe illustrated in FIG. 4A . In another embodiment, FIG.
- FIG. 4C shows a side view of the distal portion of a piercing probe 36 is a double-pointed tip 32.
- the tip 32 of the piercing probe 36 has multiple points.
- the internal edges of the tip 32 of the piercing tube 36 are rounded (not shown).
- the tip 32 of the piercing probe 36 reduces coring of the sample tube cap 37, thus the end surface of the tube may have one or more cuts or be sharpened to reduce coring. Any configuration of tip 32 capable of perforating a seal 37 of a sample tube 7 may be used.
- FIG. 5 depicts an exemplary sample probe 30 of the invention.
- the sample probe 30 is a tubular structure including an axially disposed lumen, a proximal end 28, and a distal free end 34.
- the sample probe 30 is axially disposed in and inseparable from the lumen 35 of the piercing probe 36 during the sampling step.
- the lumen 34 of the sample probe 30 opens at the distal and proximal end of the tubular structure.
- the walls of the tubular structure of the sample probe 30 are non-perforated, i.e., without holes, ports or vents.
- the free end 34 includes an opening for fluid communication between the probe lumen 33 and the exterior of the probe 30.
- the free end 34 of the probe is inserted into a sample to aspirate a sample from a sample vial 7.
- the proximal end 28 of the sample probe 30 is coupled to a seal assembly 26 which will be discussed in detail below.
- the proximal end 28 of the sample probe 30 is connectable to a supply tube or other supply member that may serve as a conduit for the introduction of fluids or gases for cleaning or rinsing the lumen 33 of the sample probe 30 or for transport of fluid by the sample probe 30, for example, to or from a sample tube 7.
- FIG. 6 illustrates a partial cut away side view of the distal portion of an exemplary sample probe 30, housed within the lumen 35 of the distal portion of an exemplary piercing probe 36 of a sampling assembly 3 according to one embodiment of the invention.
- the piercing probe 36 encloses the sample probe 30 to prevent the sample probe 30 from contacting the seal 37 of the sample vial 7.
- the barrier formed by the piercing probe 36 prevents pieces of the frangible seal 37 from partially or completely clogging or blocking the opening of the sample probe lumen 33 at the tip 34 of the sample probe 30.
- the surface area of the sample probe 30 that would otherwise require cleaning is minimized thereby decreasing wash time and quantity of wash fluids required, thereby improving the overall efficiency of the analyzer 10.
- the lumen 35 of the piercing probe 36 acts as a vent for the sample tube 7. Venting of the sample tube 7 is advantageous because venting equalizes the pressure inside the sample tube 7 with the pressure outside the sample tube 7 to ensure the accuracy of aspiration volumes. By eliminating venting ports on the piercing probe 36 that would otherwise be required to permit venting, the likelihood that fragments of the seal 37 will clog the piercing probe 36 is minimized. Reduced sample probe 30 clogging allows for greater sampling accuracy and reduce the possibility of damage to the sample probe 30, in particular, the sample probe tip 34. In addition, reduced clogging decreases the amount of time required to clean the sample probe 30 and the piercing probe 36, thereby improving the overall efficiency of the sample analyzer 10.
- FIG. 7 shows a perspective view of the distal portion of an exemplary sample probe 30 housed within the lumen 35 of the distal portion of an exemplary piercing probe 36 according to the invention.
- the tip 34 of the sample probe 30, illustrated in FIG. 7 is exposed in the opening of the lumen 35 at the distal tip 32 of the piercing probe 36.
- FIG. 8 shows another perspective view of the exemplary sample probe 30 housed within the lumen 35 of an exemplary piercing probe 36 of the invention.
- the tip 34 of the sample probe 30 (shown in outline) is withdrawn proximally into the lumen 35 of the piercing probe 36 where it is enclosed by the distal portion of the piercing probe 36 and is not exposed in the opening of the lumen 35 of the distal tip 32 of the piercing probe 36.
- the sample probe 30 and the piercing probe 36 are axially slideably moveable relative to one another.
- the distal tip 34 of the sample probe 30 is positioned, i.e., exposed in the opening of the lumen 35 of the distal tip 32 of the piercing probe 36.
- the sample probe 30 is advanced distally while the piercing probe 36 remains stationary.
- both the sample probe 30 and the piercing probe 36 are slideably moveable.
- the distal tip 34 of the sample probe 30 is positioned i.e., enclosed within the lumen 35 of the piercing probe 36 and not extended beyond the tip 32 of the piercing probe 36, as shown in FIG. 8 .
- the distal tip 34 of the sample probe 30 is positioned below, i.e., extended beyond the piercing probe tip 32, as shown in FIG. 6 , positioned within or within the opening of the lumen 35 of the tip 32 of the piercing probe 36.
- the tip 32 of the piercing probe 36 may encounter sample during the process of piercing the seal 37, portions of the piercing probe 36 proximal to the tip 32 are not immersed in sample.
- the surface area of the piercing probe 36 that requires cleaning is reduced.
- FIG. 9A is a perspective view of an exemplary closed-tube piercing probe and sample probe assembly of the invention in an unreleased position.
- FIG. 9B is a perspective view of the proximal portion of the exemplary closed-tube piercing probe and sample probe assembly of FIG. 9A .
- both the tip 32 of the piercing probe 36, and the tip 34 of the sample probe 30 are enclosed.
- the tip 32 of the piercing probe 36 is covered by the foot 22 and tip 34 of the sample probe 30 is housed within the piercing probe 36.
- the foot 22 has a lumen (best illustrated in FIG. 2B ) through which the piercing probe 36 housing the sample probe 30 pass.
- the foot 22 is coupled to a brake rod 21.
- the brake rod 21 and the foot 22 move independently of the other elements of the sampling assembly 3 and hold the sample tube 7 in place while the sampling cycle occurs.
- the brake rod 21 may be attached to the positioning arm 1.
- the sampling assembly 3 includes a seal assembly 26 that engages the proximal end 41 (See FIG. 3 ) of the piercing probe 36, sealing the proximal end 41 from the external environment.
- the seal assembly 26 provides an orifice 49 for the introduction of fluids or gases for cleaning the lumen 35 of the piercing probe 36.
- the proximal end 28 of the sample probe 30 serves as an entrance point 28 for the introduction of fluids or gases that may be used, for example, to clean the lumen of the sample probe 30.
- the proximal end 41 of the piercing probe 36 of the sampling assembly 3 sealingly joins to a length of tubing 80.
- the tubing 80 may be formed of a polymer, such as Tygon TM.
- the tubing 80 connects the proximal end 41 of the piercing probe 36 at the orifice 49 of the seal assembly 26 so as to be in fluid communication with the positive pressure gas source 70.
- the tubing 80 may be in the form of a single length of tubing, or in multiple lengths of tubing sealingly joined by additional orifices, gaskets, valves, or other sealable junctions.
- the sample collecting device 18 includes an accumulator 62 to contain pressurized air or other gaseous fluid.
- the accumulator 62 is sealingly joined, through a length of tubing 80, to the sampling assembly 3 on one end and to the positive pressure gas source 70 on the other end.
- the accumulator 62 is a container capable of containing a volume of pressurized gas and maintaining the pressurized gas at a desired magnitude of positive pressure.
- the accumulator 62 is capable of containing a volume of gas in the range of about 200 cc to 500 cc, most preferably 300 cc.
- the positive pressure gas source 70 is, for example, a positive pressure gas pump, capable of generating pressurized gas.
- pressurized gas is provided to the sample collecting device 18 through a remote positive pressure gas source, such as a centralized "in house” pressurized gas line, in fluid communication with the lumen 35 of the piercing probe.
- the positive pressure gas source 70 is provided with or without an accumulator 62.
- the accumulator 62 includes a gas pressure meter 66 and/or a gas pressure sensor 72.
- the exemplary gas pressure meter 66 provides a visual display of the current gas pressure within the accumulator 62.
- the gas pressure sensor 72 measures the gas pressure within the accumulator 62 and provides a signal to the positive pressure gas source 70, for example, a positive pressure air pump.
- the sensor 72 signals the gas source 70 to switch on and to increase the gas pressure within the accumulator 62.
- the sensor 72 signals the gas source 70 to switch off.
- the gas pressure within the accumulator 62 is preferably in a range from about 25 PSIA to 30 PSIA, more preferably from about 27 PSIA to 28 PSIA, and preferably 27 PSIA.
- the sample collecting device 18 includes a valve 40.
- the valve 40 reversibly alternates between an open position and a closed position through the movement of a switch 42.
- the valve 40 When the valve 40 is in the open position, the lumen 35 of the piercing tube 36 is in communication with the valve 40, and the tubing 80 between the free end 32 of the piercing tube 36 and the accumulator 62.
- the valve 40 When the valve 40 is in the closed position, the gas pressure in the lumen 35 between the valve 40 and the tip 32 of the piercing tube 36 maintains a first gas pressure, equal to atmospheric pressure at the free end 32 of the piercing tube 36.
- the gas pressure present between the valve 40 in the lumen 31 of the tubing 80 to the accumulator 62 maintains a second gas pressure, equal to the gas pressure generated by the positive pressure gas source 70.
- the sample collecting device 18 includes a first valve 40 and a second valve 50.
- the first valve 40 a two-way valve, opens and closes a fluid communication between the lumen 31 of the gas tubing 80 and the pressurized gas within the accumulator 62.
- the second valve 50 a three-way valve, opens and closes a fluid communication between the lumen 31 of the gas tubing 80 and an orifice 56 open to room air at atmospheric pressure. Accordingly, in the closed position, the orifice 56 of the second valve 50 is no longer patent (open), i.e., it is closed.
- the pressure in the lumen 31 is equal to atmospheric pressure, i.e., the gas pressure at the only orifice that is open, the open end 32 of the piercing tube 36 (shown in FIG. 1 ).
- the pressure within the lumen 31 between the second valve 50 and the accumulator 62 equals the pressure of the gas pressure contained within the accumulator 62.
- the lumen 31 experiences a sudden burst of positively pressurized gas.
- the pressure of the gas decreases until the entire system, including the lumen 31 and the open gas accumulator 62, equalize towards the gas pressure at the open end 32 of the piercing tube 36 (shown in FIG. 1 ).
- the first valve 40 is only opened for a few milliseconds, permitting a short blast of positively pressured gas to escape and to purge the lumen 35 of the piercing tube 36 and to dry the outside tip of the piercing tube 36, but maintaining sufficient gas pressure within the accumulator 62 for subsequent blast cycles without requiring substantial recharging of positive pressure by the gas source 70.
- the first valve 40 is opened from 10 milliseconds to 4 seconds; more preferably 30 milliseconds to 2 seconds; and most preferably 50 milliseconds to 1 second.
- the gas within the lumen 31 of the tubing 80 and the piercing tube 36 (not shown) is at a gas pressure equal to atmospheric pressure.
- the pressure within the lumen 35 of the piercing tube 36 is equal to atmospheric pressure.
- the pressure within the lumen 35 of the piercing tube 36 will equilibrate with the pressure, either positive or negative, of the sample tube 7.
- the sample tube 7 may have an internal gas pressure either higher or lower than atmospheric pressure. Additionally, aspiration of a sample from the sample tube 7 by the sample probe 30 may lower the gas pressure within the sample tube 7, and subsequently within the lumen 35 of the piercing tube 36, to a gas pressure below atmospheric pressure. In this situation, the pressure within the free end 32 of the piercing tube 36 will equilibrate with atmospheric pressure, by venting through the open orifice 56 of the second valve 50.
- Gas pressures remaining in the sampling assembly either above or below atmospheric pressure may introduce errors in the amount of sample aspirated.
- an automated aspirating probe may be programmed to aspirate sample for a predetermined period of time or for a predetermined volume, such that a standardized sample volume is aspirated during each procedure. If the sample is aspirated at a gas pressure either above or below atmospheric pressure, a timed sample aspiration may result in either too much or too little sample being aspirated, introducing errors into subsequent analyses. A vent to atmospheric pressure reduces the likelihood that such a sampling error will occur.
- the sample collecting device 18 includes a single three-way valve 100 connecting the lumen 35 of the piercing tube 36 (not shown) to the accumulator 62 and also to an orifice 56 open to room air at atmospheric pressure.
- the three-way valve 100 includes a single toggle switch 92 alternating fluid communication between the lumen 35 of the piercing tube 36 and either the accumulator 62 or the atmosphere.
- the valve 100 includes two toggle switches 94, 96 allowing three states of fluid communication.
- the sampling assembly 3 includes a solenoid 25 which controls a lock 24 for engaging the upper detent 44 or the lower detent 42 of the piercing probe 36.
- the sample probe 30 is coupled to the sampling assembly 3 via the seal assembly 26.
- Vertical movement of the piercing probe 36 is necessary to expose or enclose, i.e., cover the distal end 34 of the sample probe 30.
- the lock 24 engages the upper detent 44 the piercing probe 36 is locked in lowered position such that the tip 34 of the sample probe 30 is enclosed within the lumen 35 of the piercing probe 36 and is not exposed. If the lock 24 engages the lower detent 42, the piercing probe 36 is locked in a raised position, exposing the distal end 34 of the sample probe 30.
- the sample probe 30 remains in a constantly fixed position relative to the sampling assembly 3, while the piercing probe 36 moves relative to the sample probe 30 and the sampling assembly 3.
- the sample probe 30 may alternatively be designed to move relative to a piercing probe 36 fixed in a constant position relative to the sampling assembly 3.
- neither the sample probe 30 nor the piercing probe 36 are fixed, but both are capable of movement relative to the other and relative to the sampling assembly 3.
- the sampling assembly 3 includes an information processing unit 8, such as, for example, a PC board, controller or digital signal processor, which sends to and receives information from various sensors 45 associated with the sampling assembly 3.
- the information processing unit 8 also controls a solenoid 25 which operates to release or engage the lock 24.
- the information processing unit 8 communicates with a main computer (not shown) operating the analyzer.
- the sampling assembly 3 is attached to the positioning arm 1 by a z-rack 23, according to one embodiment of the invention.
- a motor (not shown) on the positioning arm 1 drives the z-rack 23 up and down in the z-axis (vertical), thus moving the sampling assembly 3 up and down in the z-axis, thereby moving the sample probe 30 and the piercing probe 36 upwards or downwards, piercing the cap 37 of the sample tube by the piercing probe 36 and sampling the patient fluid in the vial 7 by the sample probe 30.
- the sample probe 30 and/or the piercing probe 36 is in communication with a sensor (not shown) that detects contact of the sensor probe 30 with a fluid or a solid.
- the term sensor includes optical, mechanical, or electromechanical sensors, for example.
- a sensor may also be a circuit that detects a shift in capacitance.
- a sensor may detect motion parallel to the length of the sample probe 30 or piercing probe 36 to move the apparatus to detect the head of shoulder screws to determine the coordinates of target locations. The same motion may be used to detect fluid in tubes, cups or the cuvette. Alternatively, motion normal to the length of the probes may be used.
- the sampling probe 30 and the piercing probe 36 are joined by, for example, a circuit, connector or cable to detect motion between the sample probe 30 and piercing probe 36 to ensure motion between the probes does not cause false detection of fluid thereby to eliminate false liquid level detection.
- the invention is a method for automated sampling of patient fluid by the clinical diagnostic analyzer including a sample collecting device.
- the seal 37 of the sample tube 7 must first be pierced by the tip 32 of the piercing probe 36.
- the sample probe 30 is locked in a retracted position to prevent damage to the sample probe while the seal 37 is pierced.
- the upper detent 44 of the piercing probe 36 is engaged by the lock 24.
- the foot 22 in order for the piercing probe 36 to pierce the seal 37 of a sample tube 7, the foot 22 first contacts the seal 37.
- the brake rod 21 moves upward in the z-axis, releasing a flag from the sensor 47. This causes the z-rack 23 to drive downward and moves the piercing probe 36 through the lumen of the foot 22 to perforate the seal 37 of the tube 7.
- the piercing probe 36 may be spring-loaded to permit movement of the piercing probe 36 upward when sampling from uncapped sample tubes 7.
- the z-rack 23 drives upward, allowing the lock 24 to release and the spring (not shown) to expand, moving the piercing probe 36 upward to expose the sample probe 30 housed within. During this step, the tip 32 of the piercing probe 36 remains in the sample tube 7. The lock 24 then reengages the piercing probe 36 in the lower detent 42. The z-rack 23 subsequently drives the sampling assembly 3 downward so that the tip 34 of the sample probe 30 can aspirate the sample in the tube 7.
- the z-rack 23 then drives upward allowing the sample probe 30 and piercing probe 36 to exit the sample tube 7 simultaneously.
- the foot 22 strips the sample tube 7 from the piercing probe 36 as the piercing probe 36 is driven upward by the z-rack 23.
- the sampling assembly 3 then moves to another location of the analyzer 10 to release the sample into a cuvette 108.
- the sampling assembly travels along the z-axis of the positioning arm 1, while the positioning arm 1 moves simultaneously along the x-axis of the rail 5.
- the wash station 9 includes a deep washer for deep washing the distal portion 34 of the sample probe 30 and the distal portion 32 of the piercing probe 36.
- the deep washer includes a radial rinser for 180 rinsing the exterior of the piercing probe 36, the interior of the piercing probe 36 tip 32 and the exterior of the sample probe 30 tip 34.
- the radial rinser is attached to a radial rinse pump (not shown) which is activated when the piercing probe is brought up in the z-axis.
- the radial rinser 180 sprays a radial shower of rinse solution through a plurality of radially arranged rinse ports 182.
- the deep washer 9 may further feature an internal sample probe rinser.
- the lumen 33 of the sample probe 30 is washed by a stream of rinse fluid passed through the lumen 33 of the sample probe 30 in fluid communication with a sample probe rinser pump.
- the flow rate of rinse fluid through the lumen 33 of the sample probe 30 is in the range of about .25 to 2.0 ml/second, preferably about 1.0 to 1.5 ml/second, more preferably 1.05 ml/sec.
- an air pump or gas source 70 such as, for example, the gas source 70 described above with respect to the venting mechanism, is joined in fluid communication with the lumen 35 of the piercing probe 36.
- the pressurized gas from the gas source 70 purges residual fluid from the annular area between the sample probe 30 and the piercing probe 36 after a deep wash cycle.
- the gas source 70 is required to maintain a clear vent path needed during aspiration in the closed tube system described herein. Without a clear vent path, the internal pressure of the sample tube will not be at atmospheric pressure. A partial tube pressure above atmospheric leads to over aspiration; a partial vacuum leads to under aspiration. A clear vent path allows the immediate pressure equalization inside the sample tube and maintains good precision and accuracy for sampling.
- the gas source 70 is an air purge system such as a jet including a tube 160 with an opening positioned adjacent the piercing probe tip that supplies a short burst of air through an orifice in the foot 22 to the outside of the piercing probe tip.
- the short burst of air removes any residual rinse fluid that may remain on the piercing probe tip after the deep wash.
- the deep washer 9 includes a replaceable filter 184 for removing debris following piercing of the sample tube seal by the piercing probe 36.
- the debris is material displaced from the tube cap generated during the piercing process.
- the filter prevents the debris from blocking tubing to and from the washer.
- the filter is replaceable by laboratory personnel avoiding costly service calls. Typically, the filter is replaced every 5000 cycles.
- a verification system such as a sensor may be installed to verify the filter is in place.
- At least one advantage of the sample collecting device 3 according to the invention is that the sample tube 7 is pierced by the piercing probe 36 and the sample fluid is aspirated by the sample probe 30 without the need for the sampling assembly 3 to move in the x-axis or the y-axis. This feature reduces the time required to obtain a sample aliquot from the sample tube 7 and improves throughput time, thus increasing the efficiency of the sample analyzer 10.
- the table below A PT (tests per hour) 270 APTT (tests per hour) 270 B 228 120 compares the actual throughput of a sample collecting device according to the invention (A) for prothrombin time (PT) and activated partial thromboplastin time (APTT) to the actual throughput of a pre-existing sample collecting device (B) for the same tests.
- the sample collecting device according to the invention processes 270 PT tests/hour and 270 APTT tests per hour while the pre-existing sample collecting device processes 228 PT and 120 APTT tests per hour.
- the throughput of the sample collecting device according to the invention is more than double the throughput of the pre-existing sample collecting device.
- the tip 32 of the piercing probe 36 is positioned within the sample tube 7 from the initial pierce until the sample is aspirated, the likelihood of contamination that would otherwise result from multiple entries into the sample tube 7 is reduced.
- sampling assembly 3 includes the ability of the sample analyzer 10 utilizing the sampling assembly 3 of the invention to process a batch of sample tubes 7 where some tubes 7 are capped or sealed and some tubes 7 lack caps or seals. This is possible because the piercing probe 36 and the sample probe 30 can perform the same steps on a sample tube, regardless of whether a cap is present.
- the telescoping configuration of the sample probe 30 and the piercing probe 36 eliminates the need for movement in the x-axis or y-axis during the piercing and sampling stage enabling the sampling assembly 3 to be more easily centered on a sample tube cap 37. Accordingly, the sampling assembly 3 samples from sample tubes 7 of differing diameters and geometries, as well as samples from sample tube caps or seals 37 of differing diameters and materials. Furthermore, the ability of the sampling assembly 3 to move in the z-axis, allows the sampling assembly 3 to sample from tubes 7 of different heights in the same batch. Thus, any variety of sample vials may be placed in the sample tube receiving area 102 (see, e.g., FIG. 2A ).
- sampling assembly including the venting mechanism described herein is preferably used in aspirating a patient sample
- sampling assembly is also useful for aspirating volumes of other fluids or liquids, including reagents, for example.
- These fluids may be aspirated from any number of containers including, but not limited to vials, test tubes, and sample tubes.
- Other variations, modifications, and implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention as claimed. Accordingly the invention is not to be defined by the preceding illustrative description, but instead by the spirit and scope of the claims that follow.
- Embodiments of the invention may include the features of the following enumerated paragraphs ("paras").
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Abstract
Description
- The invention relates to a clinical diagnostic analyzer for analyzing fluid samples such as patient blood samples. More particularly, the invention relates to a closed tube sample collecting device including a piercing probe and sample probe assembly mounted on a clinical diagnostic analyzer for accessing a fluid in vial, venting mechanisms associated with the closed tube sample collecting device, and methods for sampling and clearing a closed tube sample collecting device between patient samples to prevent cross contamination of the blood samples.
- Blood and other bodily fluids handled in large quantities by medical laboratories for processing and testing present cost containment and biohazard issues for the laboratory. In order to minimize costs of testing fluids, the equipment and procedures utilized to process such samples are becoming increasingly automated so as to permit the procedures to be performed as quickly as possible with minimum labor. Automating sample processing has the additional benefit of minimizing the handling of blood and other bodily fluids that are now classified as hazardous substances.
- In order to analyze samples of patient fluids, including human blood, a sample must first be taken from the patient. Usually the sample is housed within a container to be aspirated from during analyzer operation. These sample containers are then loaded into an automatic sample analyzer. If the sample container is capped, the cap must first be removed before a sample can be aspirated for analysis. This can be done manually by the operator, or, if the sample container has a frangible seal, the analyzer may contain a piercing apparatus to break the seal on the container to allow aspiration of a fluid sample.
- Currently available commercial sample analyzers capable of piercing sealed containers have several disadvantages that reduce the effectiveness and efficiency of the sampling and analysis operations. For example, some analyzers use the sample aspirator in a dual mode to break the frangible seal, as well as to aspirate sample. The use of the sample aspirator in the dual mode may cause blockage of the sample aspirator if fragments of the seal enter the tip of the aspirator or the venting apertures disposed on the sample aspirator. Additionally, even if a separate piercing apparatus is used to break the frangible seal, when the sample aspirator alone subsequently enters the perforated seal, debris from the seal can block the sample aspirator tip and/or any venting ports disposed thereon, thus reducing the accuracy of the sample volume aspirated, and potentially damaging the sample aspirator. Clogged venting ports and aspirator tips increase the risk of cross-contamination of patient samples and also require that more time be dedicated to cleaning of the apparatus, thus increasing throughput times and decreasing the effectiveness of the analyzer.
- Furthermore, some analyzers use a piercing device that is separated from the sampling device. In some devices, the piercing device is located in close proximity to the sampling device; however, in some devices the piercing device and sampling device may be located in different areas of the analyzer. Consequently, additional time is required to first position the sample tube for piercing and to then either reposition the sample in relation to the sample aspirator, or to move the sample aspirator to the location of the sample vial. These movements increase the throughput time of the sample analyzer, thus decreasing its efficiency.
- In addition, currently available sample analyzers may only be able to aspirate sample from one type of vial or sample container at a time. Consequently, if an operator had multiple samples in different sized vials, only similar containers could be processed in the same batch. A new cycle or additional analyzer calibration would be required for each style of vial present. The inability of a sample analyzer to process different sized vials in the same batch negatively affects the throughput time of the analyzer, decreasing its efficiency.
- There is, therefore, a demonstrated need in the art for a more efficient automated sample analyzer with improved throughput rates and improved probe designs. The improved sample analyzer reduces or eliminates the problems associated with current devices used to pierce sample vial caps, reduces clogging of both the piercing and sampling mechanisms thereby reducing cross-contamination, improving the accuracy of aspirating sample volumes, and improves access to samples in a variety of differently sized sample tubes.
- The present invention provides a clinical diagnostic analyzer comprising an assembly for obtaining a sample of fluid from a fluid sample tube or vial. The invention also provides a method for sampling fluid from a fluid sample tube or vial.
- In one aspect, the invention provides a clinical diagnostic analyzer comprising a sample collecting device for sampling fluid in a container. In one embodiment, the device includes a first tube comprising a lumen and a piercing end, a second tube comprising a lumen and a free end, and a valve operatively joined to the piercing tube, the valve comprising an open position and a closed position, and a positive pressure gas source for generating positive gas pressure operatively joined to the valve. The positive gas pressure generated by the positive pressure gas source purges the piercing tube lumen when the valve is in the open position. The second tube is at least partially housed within the lumen of the first tube and the free end of the second tube transitions from an enclosed position within the lumen of the first tube to a deployed position beyond the piercing end of the first tube. At least one of the first or the second tube axially moves relative to the other. The second tube samples fluid in the container when the free end of the second tube is deployed relative to the piercing end of the first tube.
- In one embodiment, the first tube and the second tube move simultaneously with one another, while in another embodiment, the second tube is stationary and the first tube moves relative to the second tube. In yet another embodiment, the first tube is stationary while the second tube moves relative to the first tube.
- In another embodiment, the second tube is coupled to an assembly for passing a gas, e.g., air through the lumen of the second tube, while in yet another embodiment, the first tube is coupled to an assembly for passing a cleaning solution through the lumen of the first tube.
- In another embodiment, the apparatus includes a mechanism for triggering the apparatus to pierce the cap of and sample from a sample tube. The mechanism includes a sensor system and an activating member that triggers the apparatus when the member contacts the sample tube. The member may be a foot assembly.
- In a further embodiment, the piercing end of the first tube is cut on an angle to reveal an elliptical cross section. The end is beveled.
- In another embodiment, the apparatus is coupled to a first carriage assembly to permit movement of the apparatus in a first axis of the analyzer, while in a further embodiment, the first carriage assembly is coupled to a second carriage assembly to permit movement of the apparatus in a second axis of the analyzer. The analyzer may also comprise at least one motor and a computer. In another embodiment, the apparatus further comprises an information processing unit for receiving and sending information to a computer.
- In another embodiment of the invention, the first tube may be coupled to a spring-loaded assembly.
- According to another embodiment of the invention, the valve of the device is a two-way valve. The device may include one, two, or more two-way valves arranged in series or in parallel. According to another embodiment, the first valve is operatively joined to the positive pressure gas source and the second valve is operatively joined to room air at atmospheric pressure. According to an alternative embodiment, the valve is a three-way valve and the three way valve is operatively joined to the piercing tube, to the positive pressure gas source, and to room air at atmospheric pressure.
- According to another embodiment of the invention, the sample collecting device further includes an accumulator. The accumulator is operatively joined to the valve and to the positive pressure gas source. The accumulator is pressurized from about 25 PSIA to 30 PSIA; preferably 27 PSIA. According to another embodiment, the device further includes a gas pressure sensor. The gas pressure sensor is operatively joined to the positive pressure gas source.
- In another embodiment, the present invention provides a clinical diagnostic analyzer including an apparatus for sampling fluid in a container. The apparatus includes a first non-perforated tube reciprocally movable in a vertical axis comprising a lumen, a piercing end and another end in communication with a conduit, and a second non-perforated tube comprising a lumen and a free end. The second tube is inseparable during sampling from, and is at least partially housed within the lumen of the first tube. The free end of the second tube transitions from an enclosed position within the lumen of the first tube to a deployed position beyond the piercing end of the first tube. In one embodiment, the first tube moves axially relative to the second tube. In another embodiment the second tube moves axially relative to the first tube or alternatively, both tubes move axially relative to each other. The second tube samples fluid in the container when the free end of the second tube is deployed relative to the piercing end of the first tube.
- In one embodiment according to the invention, the piercing end of the first tube may be for example, beveled, cut at an angle to reveal an elliptical cross section, chamfered, or the inner edges of the free end may be rounded.
- In one embodiment, the clinical diagnostic analyzer according to the invention includes a spring operatively joined to the first tube to effect movement of the first tube. The first tube may further feature one or more detents for positioning the first tube in its vertical axis. In a particular embodiment, the analyzer includes a ' sensor system that engages a member contacting the sample tube to determine when a sample tube is in position for piercing and sampling. The member may be, for example, a foot assembly comprising a through hole.
- In one embodiment, the apparatus of the clinical diagnostic analyzer is coupled to a first carriage assembly to permit movement of the apparatus in a first axis of the analyzer. In another embodiment, the first carriage assembly is coupled to a second carriage assembly to permit movement of said apparatus in a second axis of said analyzer.
- In one embodiment the clinical diagnostic analyzer according to the invention includes a washing station. The washing station may include a washing container, a radial rinser, a filter, and/or a gas jet, or any combination of the above. In one embodiment the filter is disposed in the lumen of the washing container. The radial rinser features a plurality of radially arranged rinser ports. The apparatus according to the invention may further include an air purge system comprising a tube with an orifice positioned adjacent the tip of the first tube, the air purge system operatively joined to a gas source
- In another embodiment, the clinical diagnostic analyzer includes a pressurized gas source in communication with the lumen of the first tube for purging residual fluid in the lumen. In yet another embodiment, the clinical diagnostic analyzer features a second tube coupled to an assembly for passing fluid through the lumen of the second tube.
- In one embodiment of the invention, the first tube is operatively joined to a sensor to detect contact of the first tube with a fluid or a solid. Alternatively, the second tube is operatively joined to a sensor to detect contact of the second tube with a fluid or a solid. In yet another embodiment the first tube and the second tube are joined by a circuit to prevent signal of false detection of the other tube.
- Other aspects of the present invention will be apparent to these skilled in the art upon reading the following description and claims. While the description and drawings are of a particular embodiment, other embodiments fall within the scope of the invention.
- In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention.
-
FIG. 1 is a schematic view of a clinical diagnostic analyzer including a sample collecting device according to an illustrative embodiment of the invention. -
FIG. 2A is a front perspective view of an exemplary closed-tube sampling assembly of the invention housed within a clinical diagnostic sample analyzer. -
FIG. 2B is a side, partial cutaway view of the washing station shown inFIG. 2A according to the invention. -
FIG. 3 depicts an exemplary piercing probe of the invention. -
FIG. 4A shows a cutaway view of a portion of an exemplary piercing probe including a blunt tip and chamfered edge. -
FIG. 4B shows a side view of the portion of the exemplary piercing probe ofFIG. 4A . -
FIG. 4C shows a side view of a portion of an exemplary piercing probe with a double-pointedtip 32. -
FIG. 5 depicts an exemplary sample probe of the invention. -
FIG. 6 depicts a partial cut-away side view of the distal portion of an exemplary sample probe according to the invention, housed within the lumen of the distal portion of an exemplary piercing probe of an exemplary sampling assembly of the invention. -
FIG. 7 shows a perspective view of the distal portion of an exemplary sample probe housed within the lumen of the distal end and extended beyond the opening of an exemplary piercing probe according to the invention. -
FIG. 8 shows a perspective view of the distal portion of an exemplary sample probe housed and completely enclosed within the lumen of the distal end of an exemplary piercing probe according to the invention wherein the distal portion of the sample probe is enclosed. -
FIG. 9A is a perspective view of a sampling assembly including an exemplary closed-tube piercing probe and sample probe of the invention in an unreleased position. -
FIG. 9B is a perspective view of the proximal portion of sampling assembly including the exemplary closed-tube piercing probe and sample probe assembly ofFIG. 9A . -
FIG. 10 is a schematic view of a portion of the sample collecting device inFIG. 1 including a first valve and a second valve according to an illustrative embodiment of the invention. -
FIG. 11 is a schematic view of a portion of the sample collecting device inFIG. 1 including a valve according to another illustrative embodiment of the invention. -
FIG. 12 is a perspective view of an exemplary closed-tube piercing probe and sample probe assembly sampling assembly of the invention wherein the tip of the piercing probe and the tip of the sample probe are exposed. - The present invention is related to a telescoping piercing probe and sample probe assembly and a venting mechanism mounted on a clinical diagnostic analyzer for automated piercing and sampling of fluid in a vial. The assembly includes a sample probe housed within a piercing probe. All of the following embodiments of the invention include features that improve the efficiency and effectiveness of an automated diagnostic sample analyzer including the piercing probe and sample probe assembly, and the venting mechanism of the invention.
- Referring to
FIG. 1 , asample collecting device 18, for example, a closed tube sample collecting device, is a component of an automated clinicaldiagnostic analyzer 10 that analyzes patient blood samples. The clinicaldiagnostic analyzer 10 may further include ananalysis station 4, awash station 9, aprocessor 8, adrive motor 90 and asample tube rack 96. Thesample tube rack 96 includes a plurality ofsample tube wells 98. A patient blood sample, contained within asample tube 7, rests within asample tube well 98. It is contemplated that thesample collecting device 18 may collect samples from a variety of sized and shapedsample tubes 7, including both closedsample tubes 7, cups (not shown), vials (not shown), and open sample tubes. Theclosed sample tubes 7 include a sample tube cap or seal 37 to seal the sample from the atmosphere and particulate debris. - Referring still to
FIG. 1 , in one embodiment according to the invention thesample collecting device 18 includes asampling assembly 3 comprising a piercingtube 36 comprising an axially-disposedlumen 35, and asample aspirating probe 30 including an axially disposedlumen 33. In a further embodiment, thesample collecting device 18 may also include one ormore valves 40, anaccumulator 62, and a positivepressure gas source 70. - With reference to
FIG. 2A , in one embodiment, thesampling assembly 3 is mounted to a carriage assembly which travels via abearing rail 5 of an arm 1. The arm 1 is also attached to a second carriage assembly which travels on a second bearing rail (not shown). - With continued reference to
FIG. 2A , in one embodiment according to the invention, a cuvette dispenser (not shown) is positioned at the rear of theanalyzer 10 to dispense cuvettes (not shown) that receive the sample obtained by thesampling assembly 3. The cuvettes are transported by a tube transport mechanism (not shown) to theanalysis station 4 such as, for example, a luminometer. - Referring to
FIG. 2B , a further embodiment of theanalyzer 10 according to the invention includes awashing station 9. Thewashing station 9 cleans the piercingprobe 36 andsample probe 30 of thesampling assembly 3 after the sample removed from thesample tube 7 is dispensed into a cuvette (not shown). In one embodiment of the invention, thewashing station 9 includes acontainer 200 of washing fluid and a spray device, e.g., ashower 180 that sprays a washing fluid directed to the contaminated piercingprobe 36 and/orsample probe 30. In another embodiment, thewashing station 9 further includes afilter 184 for removing debris. Thefilter 184 may be substantially cylindrical, disc-shaped or conical. In a particular embodiment the filter is cylindrical and disposed in the lumen of the washing container. In yet another embodiment, thewashing station 9 includes ajet 160 connected to a gas source (not shown) for directing a blast of drying gas to the distal end of the piercing probe to dry the probe. - Referring again to
FIG. 2A , a computer (not shown) controls the overall activity of theanalyzer 10 by receiving input from the various sensors and information processing units of theanalyzer 10 and directing the movement of the various parts of theanalyzer 10, such as the movement of the positioning arm 1 along therail 5, according to one embodiment of the invention. The movement of the positioning arm 1 is driven by amotor 90. There may also be additional motors to drive movement of other parts of theanalyzer 10. The clinicaldiagnostic sample analyzer 10 shown here is only one example of an analyzer utilizing thesampling assembly 3 of the invention. Thesampling assembly 3 may be used according to the invention with any appropriately configured clinical diagnostic sample analyzer. -
FIG. 3 depicts anexemplary piercing probe 36 of the invention. The piercingprobe 36 is a tubular structure including a distal end, a proximal end, and an axially disposedlumen 35 that opens on the distal and proximal end of the tubular structure. The walls of the tubular structure are non-perforated; i.e., without holes, ports or vents. In one embodiment, the piercingprobe 36 is reciprocally movable in a vertical axis. - According to another embodiment, a
tip 32 for piercing asample tube 7 is disposed at the distal end of the piercingprobe 36, while the piercingprobe 36 proximal to thetip 32 has at least afirst detent 42 and asecond detent 44 proximal to thefirst detent 42. Additional detents may also be included in theprobe 36 according to alternative embodiments of the invention. According to a particular embodiment, the piercingprobe 36 includes only one detent (not shown). The first and second detents assist in positioning the piercingprobe 36 relative to thesampling probe 30 and will be discussed further below. The proximal end of the piercingprobe 36 also may be in communication with a conduit. - While in one embodiment of the invention, the
tip 32 of the piercingprobe 36 shown inFIG. 3 is beveled and reveals an elliptical cross-section, thetip 32 may be cut at any angle. As shown inFIGS. 4A-C , the tip may also be one of a variety of different shapes, e.g., diamond, circular, oval, rectangular, toothed and scalloped, for example.FIG. 4A shows a cutaway view of the distal portion of anexemplary piercing probe 36 including ablunt tip 32 that includes a chamfered edge according to one embodiment of the invention.FIG. 4B shows a side view of the portion of the exemplary piercing probe illustrated inFIG. 4A . In another embodiment,FIG. 4C shows a side view of the distal portion of a piercingprobe 36 is a double-pointedtip 32. In yet another embodiment, thetip 32 of the piercingprobe 36 has multiple points. In another embodiment, the internal edges of thetip 32 of the piercingtube 36 are rounded (not shown). In one further embodiment, thetip 32 of the piercingprobe 36 reduces coring of thesample tube cap 37, thus the end surface of the tube may have one or more cuts or be sharpened to reduce coring. Any configuration oftip 32 capable of perforating aseal 37 of asample tube 7 may be used. -
FIG. 5 depicts anexemplary sample probe 30 of the invention. Thesample probe 30 is a tubular structure including an axially disposed lumen, aproximal end 28, and a distalfree end 34. Thesample probe 30 is axially disposed in and inseparable from thelumen 35 of the piercingprobe 36 during the sampling step. Thelumen 34 of thesample probe 30 opens at the distal and proximal end of the tubular structure. The walls of the tubular structure of thesample probe 30 are non-perforated, i.e., without holes, ports or vents. Thefree end 34 includes an opening for fluid communication between theprobe lumen 33 and the exterior of theprobe 30. Thefree end 34 of the probe is inserted into a sample to aspirate a sample from asample vial 7. In one embodiment, theproximal end 28 of thesample probe 30 is coupled to aseal assembly 26 which will be discussed in detail below. Theproximal end 28 of thesample probe 30 is connectable to a supply tube or other supply member that may serve as a conduit for the introduction of fluids or gases for cleaning or rinsing thelumen 33 of thesample probe 30 or for transport of fluid by thesample probe 30, for example, to or from asample tube 7. -
FIG. 6 illustrates a partial cut away side view of the distal portion of anexemplary sample probe 30, housed within thelumen 35 of the distal portion of anexemplary piercing probe 36 of asampling assembly 3 according to one embodiment of the invention. As shown inFIG. 6 , according to one embodiment of the invention, when thesample probe 30 is positioned in thesample vial 7, the piercingprobe 36 encloses thesample probe 30 to prevent thesample probe 30 from contacting theseal 37 of thesample vial 7. The barrier formed by the piercingprobe 36 prevents pieces of thefrangible seal 37 from partially or completely clogging or blocking the opening of thesample probe lumen 33 at thetip 34 of thesample probe 30. Furthermore, because thesample probe 30 never touches theseal 37 of thesample vial 7, the surface area of thesample probe 30 that would otherwise require cleaning is minimized thereby decreasing wash time and quantity of wash fluids required, thereby improving the overall efficiency of theanalyzer 10. - In addition, in one embodiment according to the invention, the
lumen 35 of the piercingprobe 36 acts as a vent for thesample tube 7. Venting of thesample tube 7 is advantageous because venting equalizes the pressure inside thesample tube 7 with the pressure outside thesample tube 7 to ensure the accuracy of aspiration volumes. By eliminating venting ports on the piercingprobe 36 that would otherwise be required to permit venting, the likelihood that fragments of theseal 37 will clog the piercingprobe 36 is minimized. Reducedsample probe 30 clogging allows for greater sampling accuracy and reduce the possibility of damage to thesample probe 30, in particular, thesample probe tip 34. In addition, reduced clogging decreases the amount of time required to clean thesample probe 30 and the piercingprobe 36, thereby improving the overall efficiency of thesample analyzer 10. -
FIG. 7 shows a perspective view of the distal portion of anexemplary sample probe 30 housed within thelumen 35 of the distal portion of anexemplary piercing probe 36 according to the invention. Thetip 34 of thesample probe 30, illustrated inFIG. 7 , is exposed in the opening of thelumen 35 at thedistal tip 32 of the piercingprobe 36. -
FIG. 8 shows another perspective view of theexemplary sample probe 30 housed within thelumen 35 of anexemplary piercing probe 36 of the invention. As shown inFIG. 8 , thetip 34 of the sample probe 30 (shown in outline) is withdrawn proximally into thelumen 35 of the piercingprobe 36 where it is enclosed by the distal portion of the piercingprobe 36 and is not exposed in the opening of thelumen 35 of thedistal tip 32 of the piercingprobe 36. Thesample probe 30 and the piercingprobe 36 are axially slideably moveable relative to one another. For example, by withdrawing the piercingprobe 36 proximally, and maintaining thesample probe 30 stationary, thedistal tip 34 of thesample probe 30 is positioned, i.e., exposed in the opening of thelumen 35 of thedistal tip 32 of the piercingprobe 36. Alternatively, thesample probe 30 is advanced distally while the piercingprobe 36 remains stationary. In yet another embodiment of the invention, both thesample probe 30 and the piercingprobe 36 are slideably moveable. Because of the relative movement of thesample probe 30 and the piercingprobe 36, when the piercingprobe 36 punctures theseal 37 on thesample tube 7, thedistal tip 34 of thesample probe 30 is positioned i.e., enclosed within thelumen 35 of the piercingprobe 36 and not extended beyond thetip 32 of the piercingprobe 36, as shown inFIG. 8 . When ready to aspirate the sample from thesample tube 7, thedistal tip 34 of thesample probe 30 is positioned below, i.e., extended beyond the piercingprobe tip 32, as shown inFIG. 6 , positioned within or within the opening of thelumen 35 of thetip 32 of the piercingprobe 36. While thetip 32 of the piercingprobe 36 may encounter sample during the process of piercing theseal 37, portions of the piercingprobe 36 proximal to thetip 32 are not immersed in sample. By minimizing the surface area of the piercingprobe 36 that is exposed to sample, the surface area of the piercingprobe 36 that requires cleaning is reduced. -
FIG. 9A is a perspective view of an exemplary closed-tube piercing probe and sample probe assembly of the invention in an unreleased position.FIG. 9B is a perspective view of the proximal portion of the exemplary closed-tube piercing probe and sample probe assembly ofFIG. 9A . In the unreleased position shown inFIG. 9A , both thetip 32 of the piercingprobe 36, and thetip 34 of thesample probe 30 are enclosed. Thetip 32 of the piercingprobe 36 is covered by thefoot 22 andtip 34 of thesample probe 30 is housed within the piercingprobe 36. - With continued reference to
FIG. 9A , thefoot 22 has a lumen (best illustrated inFIG. 2B ) through which the piercingprobe 36 housing thesample probe 30 pass. According to one embodiment of the invention, thefoot 22 is coupled to abrake rod 21. Thebrake rod 21 and thefoot 22 move independently of the other elements of thesampling assembly 3 and hold thesample tube 7 in place while the sampling cycle occurs. In a further embodiment, thebrake rod 21 may be attached to the positioning arm 1. - With continued reference to
FIG. 9A andFIG. 9B , according to one embodiment of the invention, thesampling assembly 3 includes aseal assembly 26 that engages the proximal end 41 (SeeFIG. 3 ) of the piercingprobe 36, sealing theproximal end 41 from the external environment. In one embodiment, theseal assembly 26 provides anorifice 49 for the introduction of fluids or gases for cleaning thelumen 35 of the piercingprobe 36. In one embodiment, theproximal end 28 of thesample probe 30 serves as anentrance point 28 for the introduction of fluids or gases that may be used, for example, to clean the lumen of thesample probe 30. - Referring back to
FIG. 1 according to one embodiment, theproximal end 41 of the piercingprobe 36 of thesampling assembly 3 sealingly joins to a length oftubing 80. Thetubing 80 may be formed of a polymer, such as Tygon ™. Thetubing 80 connects theproximal end 41 of the piercingprobe 36 at theorifice 49 of theseal assembly 26 so as to be in fluid communication with the positivepressure gas source 70. Thetubing 80 may be in the form of a single length of tubing, or in multiple lengths of tubing sealingly joined by additional orifices, gaskets, valves, or other sealable junctions. - With continued reference to
FIG. 1 , in certain embodiments, thesample collecting device 18 includes anaccumulator 62 to contain pressurized air or other gaseous fluid. Theaccumulator 62 is sealingly joined, through a length oftubing 80, to thesampling assembly 3 on one end and to the positivepressure gas source 70 on the other end. Theaccumulator 62 is a container capable of containing a volume of pressurized gas and maintaining the pressurized gas at a desired magnitude of positive pressure. According to one embodiment of the invention, theaccumulator 62 is capable of containing a volume of gas in the range of about 200 cc to 500 cc, most preferably 300 cc. - With continued reference to
FIG. 1 , according to one embodiment of the invention, the positivepressure gas source 70 is, for example, a positive pressure gas pump, capable of generating pressurized gas. According to an alternative embodiment, pressurized gas is provided to thesample collecting device 18 through a remote positive pressure gas source, such as a centralized "in house" pressurized gas line, in fluid communication with thelumen 35 of the piercing probe. In one embodiment, the positivepressure gas source 70 is provided with or without anaccumulator 62. - In another embodiment of the invention, referring still to
FIG. 1 , theaccumulator 62 includes agas pressure meter 66 and/or agas pressure sensor 72. The exemplarygas pressure meter 66 provides a visual display of the current gas pressure within theaccumulator 62. Thegas pressure sensor 72 measures the gas pressure within theaccumulator 62 and provides a signal to the positivepressure gas source 70, for example, a positive pressure air pump. When the gas pressure in theaccumulator 62 falls below the desired gas pressure magnitude, thesensor 72 signals thegas source 70 to switch on and to increase the gas pressure within theaccumulator 62. Once thegas pressure sensor 72 measures a gas pressure at the desired magnitude, thesensor 72 signals thegas source 70 to switch off. The combination of the sensor - 72 and the
gas source 70 maintains a near constant desired gas pressure within theaccumulator 62. According to one embodiment of the invention, the gas pressure within theaccumulator 62 is preferably in a range from about 25 PSIA to 30 PSIA, more preferably from about 27 PSIA to 28 PSIA, and preferably 27 PSIA. - Referring still to
FIG. 1 , according to one embodiment of the invention, thesample collecting device 18 includes avalve 40. Thevalve 40 reversibly alternates between an open position and a closed position through the movement of aswitch 42. When thevalve 40 is in the open position, thelumen 35 of the piercingtube 36 is in communication with thevalve 40, and thetubing 80 between thefree end 32 of the piercingtube 36 and theaccumulator 62. When thevalve 40 is in the closed position, the gas pressure in thelumen 35 between thevalve 40 and thetip 32 of the piercingtube 36 maintains a first gas pressure, equal to atmospheric pressure at thefree end 32 of the piercingtube 36. When thevalve 40 is in the closed position, the gas pressure present between thevalve 40 in thelumen 31 of thetubing 80 to theaccumulator 62 maintains a second gas pressure, equal to the gas pressure generated by the positivepressure gas source 70. - Referring now to
FIG. 10 , thesample collecting device 18, according to an alternative embodiment, includes afirst valve 40 and asecond valve 50. According to this embodiment, thefirst valve 40, a two-way valve, opens and closes a fluid communication between thelumen 31 of thegas tubing 80 and the pressurized gas within theaccumulator 62. Thesecond valve 50, a three-way valve, opens and closes a fluid communication between thelumen 31 of thegas tubing 80 and anorifice 56 open to room air at atmospheric pressure. Accordingly, in the closed position, theorifice 56 of thesecond valve 50 is no longer patent (open), i.e., it is closed. When thefirst valve 40 is in the closed position and thesecond valve 50 is in the closed position, the pressure in thelumen 31 is equal to atmospheric pressure, i.e., the gas pressure at the only orifice that is open, theopen end 32 of the piercing tube 36 (shown inFIG. 1 ). - With continued reference to
FIG. 10 , when thefirst valve 40 is in the open position and thesecond valve 50 is in the closed position, the pressure within thelumen 31 between thesecond valve 50 and theaccumulator 62 equals the pressure of the gas pressure contained within theaccumulator 62. When thefirst valve 40 is initially opened, thelumen 31 experiences a sudden burst of positively pressurized gas. As thefirst valve 40 remains open, the pressure of the gas decreases until the entire system, including thelumen 31 and theopen gas accumulator 62, equalize towards the gas pressure at theopen end 32 of the piercing tube 36 (shown inFIG. 1 ). According to one embodiment of the invention, thefirst valve 40 is only opened for a few milliseconds, permitting a short blast of positively pressured gas to escape and to purge thelumen 35 of the piercingtube 36 and to dry the outside tip of the piercingtube 36, but maintaining sufficient gas pressure within theaccumulator 62 for subsequent blast cycles without requiring substantial recharging of positive pressure by thegas source 70. According to one embodiment of the invention, thefirst valve 40 is opened from 10 milliseconds to 4 seconds; more preferably 30 milliseconds to 2 seconds; and most preferably 50 milliseconds to 1 second. - Referring still to
FIG. 10 , when thefirst valve 40 is in the closed position and thesecond valve 50 is in the open position, the gas within thelumen 31 of thetubing 80 and the piercing tube 36 (not shown) is at a gas pressure equal to atmospheric pressure. Referring again toFIG. 1 , when thefree end 32 of the piercingtube 36 is outside thesample tube 7, the pressure within thelumen 35 of the piercingtube 36 is equal to atmospheric pressure. Alternatively, when thefree end 32 of the piercingtube 36 is extended into thesample tube 7, the pressure within thelumen 35 of the piercingtube 36 will equilibrate with the pressure, either positive or negative, of thesample tube 7. For example, if thesample tube 7 is sealed with asample tube cap 37, thesample tube 7 may have an internal gas pressure either higher or lower than atmospheric pressure. Additionally, aspiration of a sample from thesample tube 7 by thesample probe 30 may lower the gas pressure within thesample tube 7, and subsequently within thelumen 35 of the piercingtube 36, to a gas pressure below atmospheric pressure. In this situation, the pressure within thefree end 32 of the piercingtube 36 will equilibrate with atmospheric pressure, by venting through theopen orifice 56 of thesecond valve 50. - Gas pressures remaining in the sampling assembly either above or below atmospheric pressure may introduce errors in the amount of sample aspirated. For example, an automated aspirating probe may be programmed to aspirate sample for a predetermined period of time or for a predetermined volume, such that a standardized sample volume is aspirated during each procedure. If the sample is aspirated at a gas pressure either above or below atmospheric pressure, a timed sample aspiration may result in either too much or too little sample being aspirated, introducing errors into subsequent analyses. A vent to atmospheric pressure reduces the likelihood that such a sampling error will occur.
- Now referring to
FIG. 11 , in an alternative embodiment, thesample collecting device 18 includes a single three-way valve 100 connecting thelumen 35 of the piercing tube 36 (not shown) to theaccumulator 62 and also to anorifice 56 open to room air at atmospheric pressure. According to one embodiment of this invention, the three-way valve 100 includes asingle toggle switch 92 alternating fluid communication between thelumen 35 of the piercingtube 36 and either theaccumulator 62 or the atmosphere. According to an alternative embodiment, thevalve 100 includes twotoggle switches lumen 35 of the piercing tube 36 (not shown) is only open at itsfree end 32 and the gas pressure within thelumen 35 tends toward (atmospheric pressure,) the gas pressure at thefree end 32. When thefirst switch 94 is in its closed position and thesecond switch 96 is in its open position, the gas pressure in thelumen 31 tends toward atmospheric pressure. When thefirst switch 94 is in its open position and thesecond switch 96 is in its closed position, thelumen 35 is exposed to the pressurized gas stored in and released from theaccumulator 62. It is contemplated that alternative valve schematics, including at least one three-way valve or at least two two-way valves combinations of two-way and three-way valves, may be utilized that allow alternation between the at least two desired states. - Referring now to
FIG. 12 , in one embodiment according to the invention, thesampling assembly 3 includes asolenoid 25 which controls alock 24 for engaging theupper detent 44 or thelower detent 42 of the piercingprobe 36. - In one embodiment according to the invention, the
sample probe 30 is coupled to thesampling assembly 3 via theseal assembly 26. Vertical movement of the piercingprobe 36 is necessary to expose or enclose, i.e., cover thedistal end 34 of thesample probe 30. When thelock 24 engages theupper detent 44, the piercingprobe 36 is locked in lowered position such that thetip 34 of thesample probe 30 is enclosed within thelumen 35 of the piercingprobe 36 and is not exposed. If thelock 24 engages thelower detent 42, the piercingprobe 36 is locked in a raised position, exposing thedistal end 34 of thesample probe 30. Thus, in one embodiment, thesample probe 30 remains in a constantly fixed position relative to thesampling assembly 3, while the piercingprobe 36 moves relative to thesample probe 30 and thesampling assembly 3. However, in another embodiment, thesample probe 30 may alternatively be designed to move relative to a piercingprobe 36 fixed in a constant position relative to thesampling assembly 3. In a further embodiment, neither thesample probe 30 nor the piercingprobe 36 are fixed, but both are capable of movement relative to the other and relative to thesampling assembly 3. - With continued reference to
FIG. 12 , in one embodiment of the invention, thesampling assembly 3 includes aninformation processing unit 8, such as, for example, a PC board, controller or digital signal processor, which sends to and receives information fromvarious sensors 45 associated with thesampling assembly 3. Theinformation processing unit 8 also controls asolenoid 25 which operates to release or engage thelock 24. In addition, in one embodiment according to the invention, theinformation processing unit 8 communicates with a main computer (not shown) operating the analyzer. - With continued reference to
FIG. 12 , thesampling assembly 3 is attached to the positioning arm 1 by a z-rack 23, according to one embodiment of the invention. A motor (not shown) on the positioning arm 1 drives the z-rack 23 up and down in the z-axis (vertical), thus moving thesampling assembly 3 up and down in the z-axis, thereby moving thesample probe 30 and the piercingprobe 36 upwards or downwards, piercing thecap 37 of the sample tube by the piercingprobe 36 and sampling the patient fluid in thevial 7 by thesample probe 30. In one embodiment according to the invention, thesample probe 30 and/or the piercingprobe 36 is in communication with a sensor (not shown) that detects contact of thesensor probe 30 with a fluid or a solid. As used throughout the specification, the term sensor includes optical, mechanical, or electromechanical sensors, for example. A sensor may also be a circuit that detects a shift in capacitance. For example, a sensor may detect motion parallel to the length of thesample probe 30 or piercingprobe 36 to move the apparatus to detect the head of shoulder screws to determine the coordinates of target locations. The same motion may be used to detect fluid in tubes, cups or the cuvette. Alternatively, motion normal to the length of the probes may be used. In yet another embodiment, thesampling probe 30 and the piercingprobe 36 are joined by, for example, a circuit, connector or cable to detect motion between thesample probe 30 and piercingprobe 36 to ensure motion between the probes does not cause false detection of fluid thereby to eliminate false liquid level detection. - In one aspect, the invention is a method for automated sampling of patient fluid by the clinical diagnostic analyzer including a sample collecting device. In order to obtain the sample from a
sample tube 7 containing the patient sample, theseal 37 of thesample tube 7 must first be pierced by thetip 32 of the piercingprobe 36. Before piercing theseal 37, thesample probe 30 is locked in a retracted position to prevent damage to the sample probe while theseal 37 is pierced. - Referring to
FIGS. 9A and9B , in a first position, theupper detent 44 of the piercingprobe 36 is engaged by thelock 24. This positions thesample probe 30 in a retracted position relative to the piercingprobe 36, for example as shown inFIG. 9A , such that thetip 34 of thesample probe 30 is enclosed by the piercingprobe 36 and will not be exposed or damaged during theseal 37 piercing step. - With continued reference to
FIG. 9A , in order for the piercingprobe 36 to pierce theseal 37 of asample tube 7, thefoot 22 first contacts theseal 37. When thefoot 22 contacts the top of asample tube 7, thebrake rod 21 moves upward in the z-axis, releasing a flag from the sensor 47. This causes the z-rack 23 to drive downward and moves the piercingprobe 36 through the lumen of thefoot 22 to perforate theseal 37 of thetube 7. In one embodiment of the invention, the piercingprobe 36 may be spring-loaded to permit movement of the piercingprobe 36 upward when sampling fromuncapped sample tubes 7. When accessing samples in cappedtubes 7, once the piercingprobe 36 enters thecap 37, friction prevents the spring from releasing and moving the piercingprobe 36 upwards. Therefore, once the seal is broken, the z-rack 23 drives upward, allowing thelock 24 to release and the spring (not shown) to expand, moving the piercingprobe 36 upward to expose thesample probe 30 housed within. During this step, thetip 32 of the piercingprobe 36 remains in thesample tube 7. Thelock 24 then reengages the piercingprobe 36 in thelower detent 42. The z-rack 23 subsequently drives thesampling assembly 3 downward so that thetip 34 of thesample probe 30 can aspirate the sample in thetube 7. The z-rack 23 then drives upward allowing thesample probe 30 and piercingprobe 36 to exit thesample tube 7 simultaneously. Thefoot 22 strips thesample tube 7 from the piercingprobe 36 as the piercingprobe 36 is driven upward by the z-rack 23. - Referring back to
FIG. 2A , thesampling assembly 3 then moves to another location of theanalyzer 10 to release the sample into a cuvette 108. To move in the x-axis and y-axis, the sampling assembly travels along the z-axis of the positioning arm 1, while the positioning arm 1 moves simultaneously along the x-axis of therail 5. - With reference to
FIG. 2B , in one embodiment according to the invention, thewash station 9 includes a deep washer for deep washing thedistal portion 34 of thesample probe 30 and thedistal portion 32 of the piercingprobe 36. The deep washer includes a radial rinser for 180 rinsing the exterior of the piercingprobe 36, the interior of the piercingprobe 36tip 32 and the exterior of thesample probe 30tip 34. The radial rinser is attached to a radial rinse pump (not shown) which is activated when the piercing probe is brought up in the z-axis. Theradial rinser 180 sprays a radial shower of rinse solution through a plurality of radially arranged rinseports 182. Thedeep washer 9 may further feature an internal sample probe rinser. - The
lumen 33 of thesample probe 30 is washed by a stream of rinse fluid passed through thelumen 33 of thesample probe 30 in fluid communication with a sample probe rinser pump. The flow rate of rinse fluid through thelumen 33 of thesample probe 30 is in the range of about .25 to 2.0 ml/second, preferably about 1.0 to 1.5 ml/second, more preferably 1.05 ml/sec. - In a further embodiment, an air pump or
gas source 70 such as, for example, thegas source 70 described above with respect to the venting mechanism, is joined in fluid communication with thelumen 35 of the piercingprobe 36. The pressurized gas from thegas source 70 purges residual fluid from the annular area between thesample probe 30 and the piercingprobe 36 after a deep wash cycle. Thegas source 70 is required to maintain a clear vent path needed during aspiration in the closed tube system described herein. Without a clear vent path, the internal pressure of the sample tube will not be at atmospheric pressure. A partial tube pressure above atmospheric leads to over aspiration; a partial vacuum leads to under aspiration. A clear vent path allows the immediate pressure equalization inside the sample tube and maintains good precision and accuracy for sampling.
In a further embodiment according to the invention, thegas source 70 is an air purge system such as a jet including atube 160 with an opening positioned adjacent the piercing probe tip that supplies a short burst of air through an orifice in thefoot 22 to the outside of the piercing probe tip. The short burst of air removes any residual rinse fluid that may remain on the piercing probe tip after the deep wash. - In another embodiment, the
deep washer 9 includes areplaceable filter 184 for removing debris following piercing of the sample tube seal by the piercingprobe 36. The debris is material displaced from the tube cap generated during the piercing process. The filter prevents the debris from blocking tubing to and from the washer. The filter is replaceable by laboratory personnel avoiding costly service calls. Typically, the filter is replaced every 5000 cycles. A verification system such as a sensor may be installed to verify the filter is in place. - At least one advantage of the
sample collecting device 3 according to the invention is that thesample tube 7 is pierced by the piercingprobe 36 and the sample fluid is aspirated by thesample probe 30 without the need for thesampling assembly 3 to move in the x-axis or the y-axis. This feature reduces the time required to obtain a sample aliquot from thesample tube 7 and improves throughput time, thus increasing the efficiency of thesample analyzer 10. For example, the table belowA PT (tests per hour) 270 APTT (tests per hour) 270 B 228 120 - Furthermore, because the
tip 32 of the piercingprobe 36 is positioned within thesample tube 7 from the initial pierce until the sample is aspirated, the likelihood of contamination that would otherwise result from multiple entries into thesample tube 7 is reduced. - Other advantages of the
sampling assembly 3 according to the invention described herein include the ability of thesample analyzer 10 utilizing thesampling assembly 3 of the invention to process a batch ofsample tubes 7 where sometubes 7 are capped or sealed and sometubes 7 lack caps or seals. This is possible because the piercingprobe 36 and thesample probe 30 can perform the same steps on a sample tube, regardless of whether a cap is present. - Furthermore, the telescoping configuration of the
sample probe 30 and the piercingprobe 36 eliminates the need for movement in the x-axis or y-axis during the piercing and sampling stage enabling thesampling assembly 3 to be more easily centered on asample tube cap 37. Accordingly, thesampling assembly 3 samples fromsample tubes 7 of differing diameters and geometries, as well as samples from sample tube caps orseals 37 of differing diameters and materials. Furthermore, the ability of thesampling assembly 3 to move in the z-axis, allows thesampling assembly 3 to sample fromtubes 7 of different heights in the same batch. Thus, any variety of sample vials may be placed in the sample tube receiving area 102 (see, e.g.,FIG. 2A ). - While the sampling assembly including the venting mechanism described herein is preferably used in aspirating a patient sample, the sampling assembly is also useful for aspirating volumes of other fluids or liquids, including reagents, for example. These fluids may be aspirated from any number of containers including, but not limited to vials, test tubes, and sample tubes. Other variations, modifications, and implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention as claimed. Accordingly the invention is not to be defined by the preceding illustrative description, but instead by the spirit and scope of the claims that follow.
- Embodiments of the invention may include the features of the following enumerated paragraphs ("paras").
- 1. A clinical diagnostic analyzer comprising:
- an apparatus for sampling fluid in a container, said apparatus comprising,
- a first non-perforated tube reciprocally movable in a vertical axis comprising a lumen, a piercing end and another end in communication with a conduit,
- a second non-perforated tube comprising a lumen and a free end, said second tube inseparable during sampling from said lumen of said first tube and at least partially housed within the lumen of said first tube, wherein said free end transitions from an enclosed position within the lumen of said first tube to a deployed position beyond said piercing end of said first tube, and
- at least one of said first or said second tubes is axially moveable relative to the other, wherein said second tube samples fluid in said container when said free end of said second tube is deployed relative to said piercing end of said first tube.
- 2. The clinical diagnostic analyzer of para 1 wherein said piercing end of said first tube is beveled and cut at an angle to reveal an elliptical cross section.
- 3. The clinical diagnostic analyzer of para 1 wherein said first tube and said second tube move simultaneously.
- 4. The clinical diagnostic analyzer of para 1 wherein said second tube is stationary and said first tube moves relative to said second tube.
- 5. The clinical diagnostic analyzer of para 1 further comprising a spring wherein the spring is operatively joined to the first tube to effect movement of the first tube.
- 6. The clinical diagnostic analyzer of para 1 wherein said first tube further comprises a plurality of detents.
- 7. The clinical diagnostic analyzer of para 1 wherein a sensor system engaged by a member contacting the sample tube determines when a sample tube is in position for piercing and sampling.
- 8. The clinical diagnostic analyzer of
para 7 wherein said member comprises a foot assembly comprising a through hole. - 9. The clinical diagnostic analyzer of para 1 wherein said apparatus is coupled to a first carriage assembly to permit movement of said apparatus in a first axis.
- 10. The clinical diagnostic analyzer of
para 9 wherein said first carriage assembly is coupled to a second carriage assembly to permit movement of said apparatus in a second axis. - 11. The clinical diagnostic analyzer of para 1 further comprising a washing station comprising a washing container, a radial rinser, a filter, and a gas jet.
- 12. The clinical diagnostic analyzer of para 1 further comprising a pressurized gas source in communication with the lumen of said first tube for purging residual fluid or debris in the lumen.
- 13. The clinical diagnostic analyzer of para 11 wherein said filter is disposed within said washing container.
- 14. The clinical diagnostic analyzer of para 1 wherein the second tube is coupled to an assembly for passing fluid through the lumen of said second tube.
- 15. The clinical diagnostic analyzer of para 1 wherein said first tube is coupled to an assembly for passing a fluid or a gas through the lumen of said first tube.
- 16. The clinical diagnostic analyzer of para 1 further comprising an air purge system comprising a tube with an orifice positioned adjacent the tip of said first tube, said air purge system operatively joined to a gas source.
- 17. The clinical diagnostic analyzer of para 1 wherein the first tube is stationary and the second tube moves relative to the first tube.
- 18. The clinical diagnostic analyzer of para 16 further comprising a motor wherein the motor is operatively joined to the second tube.
- 19. The clinical diagnostic analyzer of para 1 wherein said first tube is operatively joined to a sensor to detect contact of said first tube with a fluid or a solid.
- 20. The clinical diagnostic analyzer of para 1 where said second tube is operatively joined to a sensor to detect contact of said second tube with a fluid or a solid.
- 21. The clinical diagnostic analyzer of para 1 wherein said first tube and said second tube are joined by a circuit to prevent signal of false detection of the other tube.
- 22. The clinical diagnostic analyzer of para 1 further comprising a foot for stripping the container from the first tube.
- 23. The clinical diagnostic analyzer of para 1 further comprising a rinser comprising a plurality of radially arranged rinser ports.
- 24. A sample collecting device for sampling a body fluid in a sample tube comprising:
- (a) a piercing tube comprising a lumen;
- (b) a sample aspirating probe;
- (c) a positive pressure gas source for generating positive gas pressure; and
- (d) a valve operatively connecting the piercing tube, the valve comprising an open position and a closed position,
wherein said positive gas pressure generated by said positive pressure gas source purges said piercing tube lumen when said valve is in said open position.
- 25. The device of
para 24 wherein the piercing tube further comprises a free end. - 26. The device of
para 25 wherein the free end is a cutting end. - 27. The device of
para 25 wherein the free end is beveled. - 28. The device of
para 25 wherein the free end is chamfered. - 29. The device of
para 24 wherein said sample aspirating probe is disposed within said lumen. - 30. The device of
para 24 wherein the sample aspirating probe and the piercing tube are selectively moveable relative to one another. - 31. The device of
para 24 wherein the valve is a two-way valve. - 32. The device of
para 31 further comprising a second two-way valve. - 33. The device of
para 32 wherein the first valve and the second valve are connected in parallel. - 34. The device of
para 32 wherein the first valve is operatively joined to said positive pressure gas source, the second valve is operatively joined to room air at atmospheric pressure, and the first and second valves are operatively joined to the piercer tube. - 35. The device of
para 24 wherein the valve is a three-way valve. - 36. The device of
para 35 wherein the three way valve is operatively joined to said piercing tube, to said positive pressure gas source, and to room air at atmospheric pressure. - 37. The device of
para 24 further comprising an accumulator. - 38. The device of
para 37 wherein the accumulator is operatively joined to said valve and to said positive pressure gas source to increase volume of gas flow when the valve is in the open position. - 39. The device of
para 37 wherein the accumulator is pressurized from 25 PSIA to 30 PSIA. - 40. The device of para 39 wherein the accumulator is pressurized from 27 PSIA to 28 PSIA.
- 41. The device of
para 24 further comprising a gas pressure sensor. - 42. The device of
para 41 wherein the gas pressure sensor is operatively joined to the positive pressure gas source. - 43. The device of
para 24 further comprising a washing station. - 44. The device of
para 25 wherein the internal edges of the free end are rounded. - 45. The device of
para 24 further comprising a three-axis translational movement rack. - 46. The device of para 43 wherein the washing station houses a replaceable filter for removal of debris from purging of the piercing tube.
- 47. The device of para 43 further comprising a spray rinser with multiple holes arranged radially to spray the external surfaces of the piercing tube.
- 48. The device of para 43 further comprising a spray rinser with multiple holes arranged radially to spray the external surfaces of the sample aspirating probe.
- 49. The device of
para 35 further comprising a second three-way valve. - 50. The device of
para 35 wherein the first valve and second valve are connected in series. - 51. A method for flushing a sample collecting assembly, comprising the steps of:
- (a) providing a piercing tube comprising a lumen, a valve operatively joined to the piercing tube, the valve comprising an open position and a closed position, a positive pressure gas source for generating positive gas pressure, operatively joined to the valve and a sample tube, wherein said sample tube is axially disposed in the lumen of said piercing tube;
- (b) placing said valve in said closed position;
- (c) operating said positive pressure gas source to generate a positive gas pressure;
- (d) switching said valve from said closed position to said open position; and
- (d) releasing said positive pressure gas into said lumen;
wherein said positive gas pressure flushes said tube lumen.
Claims (13)
- A method for analyzing a sample in a sample container, comprising:(i) providing a sample collecting device comprising a sampling assembly comprising,(a) a first tube comprising a lumen and an upper detent and a lower detent;(b) a locking mechanism,(c) a second tube comprising a lumen and a free end, wherein said second tube is enclosed within the lumen of said first tube; and,(d) a system for moving said first tube and said second tube relative to each other in a vertical axis comprising:a z-rack operatively joined to said first and second tubes;
one or more motion sensors for detecting motion parallel to the length of at least one of the first tube or the second tube and a foot assembly wherein said one or more motion sensors is engaged by said foot assembly to determine when said container is in a position for piercing, anda motor operatively connected to said z-rack for driving said z-rack;(ii) reversibly engaging said locking mechanism with said lower detent of said first tube;(iii) contacting said foot assembly with said sample container;(iv) driving said Z-rack vertically via said motor and in response to said sensors, moving said first tube in a vertical axis from a first position to a second position into said sample container and piercing a seal of said sample container;(v) axially moving the free end of said second tube from an enclosed position within the lumen of the first tube to a deployed position;(vi) collecting the sample from the sample container with the free end of the second tube, wherein said second tube is operatively joined to a pump;(vii) providing an analysis station in communication with said second tube; and,(viii) analyzing said sample. - The method of claim 1, the said first tube further comprises a tip, wherein said tip of said first tube is bevelled and cut at an angle to reveal an elliptical cross section.
- The method of claim 1, wherein the second tube remains in a stationary position relative to the sampling assembly, while the first tube moves relative to the second tube and the sampling assembly.
- The method of claim 1, wherein the sampling assembly further comprises a spring, wherein the spring is operatively joined to the first tube to effect movement of the first tube.
- The method of claim 1, further comprising:coupling the sampling assembly to a first carriage assembly to permit movement of said sampling assembly in a first axis; andcoupling said first carriage assembly to a second carriage assembly to permit movement of said sampling assembly in a second axis.
- The method of claim 5, wherein the first carriage assembly coupled to the sampling assembly is mounted on an arm with a bearing rail to permit movement of the sampling assembly in the first axis, wherein the second carriage assembly coupled to the first carriage assembly is mounted on said arm with the said bearing rail to permit movement of the sampling assembly in the second axis.
- The method of claim 1 wherein said upper and said lower detents position the first tube relative to the second tube.
- The method of claim 1, wherein said sample is a patient fluid.
- The method of claim 1 further comprising transporting said sample by the second tube via a proximal end connectable to a supply member that serves as a conduit to transport said sample by the second tube.
- The method of claim 1 further comprising venting the sample container by the lumen of the first tube.
- The method of claim 3 wherein said venting equalizes inside pressure of the sample container with outside pressure of the sample container.
- The method of claim 1 wherein prior to said collecting step said second tube is locked in a retracted position by said locking mechanism.
- The method of claim 1 wherein said upper and said lower detents position the first tube relative to the second tube.
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US67861505P | 2005-05-06 | 2005-05-06 | |
US67859705P | 2005-05-06 | 2005-05-06 | |
EP06759079.4A EP1877805B1 (en) | 2005-05-06 | 2006-05-04 | Telescoping closed-tube sampling assembly |
PCT/US2006/017238 WO2006121789A2 (en) | 2005-05-06 | 2006-05-04 | Telescoping closed-tube sampling assembly |
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EP06759079.4A Division EP1877805B1 (en) | 2005-05-06 | 2006-05-04 | Telescoping closed-tube sampling assembly |
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EP3742176A1 true EP3742176A1 (en) | 2020-11-25 |
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EP06759079.4A Active EP1877805B1 (en) | 2005-05-06 | 2006-05-04 | Telescoping closed-tube sampling assembly |
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EP (2) | EP3742176A1 (en) |
JP (2) | JP5179350B2 (en) |
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CA (1) | CA2606638C (en) |
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EP1877805A2 (en) | 2008-01-16 |
AU2006244476A1 (en) | 2006-11-16 |
JP5179350B2 (en) | 2013-04-10 |
EP1877805B1 (en) | 2020-12-23 |
US8758702B2 (en) | 2014-06-24 |
WO2006121789B1 (en) | 2007-03-08 |
CA2606638C (en) | 2014-07-08 |
JP5669322B2 (en) | 2015-02-12 |
US20140302610A1 (en) | 2014-10-09 |
AU2006244476B2 (en) | 2011-09-29 |
WO2006121789A2 (en) | 2006-11-16 |
WO2006121789A3 (en) | 2007-01-25 |
JP2013064751A (en) | 2013-04-11 |
US20060263250A1 (en) | 2006-11-23 |
JP2008542689A (en) | 2008-11-27 |
WO2006121789A8 (en) | 2008-02-28 |
CA2606638A1 (en) | 2006-11-16 |
WO2006121789A9 (en) | 2008-05-29 |
ES2852648T3 (en) | 2021-09-14 |
US9817010B2 (en) | 2017-11-14 |
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